Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds

September 5, 2020 updated by: Medical Coherence LLC

Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds

This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at least 3 months.

Eligible subjects will be randomized to either Treatment group or Control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks.

Study assessments and adverse events monitoring will be also performed throughout the study.

Study Overview

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Haifa, Israel
        • Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide signed and dated Informed Consent Form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged 18 to 90
  • Having a DFU of at least 3 months duration that had not improved after prior standard wound treatments
  • HbA1c of <11.0
  • Size of wounds: 1-10 cm2
  • Having DFU of grades 2 or 3 according to Wagner's classification

Exclusion Criteria:

  • Immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes).
  • Uncontrolled Diabetes defined as an HbA1c of > 11.0
  • Arterial insufficiency, Doppler vascular assessment (if needed- Ankle Brachial Index (ABI) < 0.6)
  • Osteomyelitis in the bone.
  • Photosensitivity
  • Pregnancy
  • Presence of any suspicious pre-cancerous or cancerous lesions, or having cancer.
  • Being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing.
  • Being on medications that might cause photosensitivity.
  • Participation in any other clinical trial testing a device or drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group

The treatment group will be treated with the MC-8XL laser device, emitting 808 nm laser beam with a green laser beam.

Intervention: MC-8XL low level laser device and Standard wound care

The MC-8XL, a handheld Low Level Laser Therapy (LLLT) device, comprised of an infrared laser diode that generates wavelength of 808 nm and a green laser diode with a wavelength of 525 nm will be used to treat the experimental group.

Along with the active LLLT, generally accepted standard wound care procedures will be used during the clinical trial by a qualified study nurse or doctor. These procedures will include wound cleaning and drying before irradiation with the laser device (sham or active). Each ulcer will be also assessed and debrided if needed.

After irradiation, each ulcer will be dressed with saline gauze dressing and offloaded.

Sham Comparator: Control group

The control group will receive treatment with a sham laser device, emitting a low power green light with inactive Infrared (IR) laser for indication only.

Intervention: Sham laser device and Standard wound care

The Sham device is of similar appearance, emitting only green light for indication with a wavelength of 525 nm of a low power, with inactive IR laser which will be used in the Control group.

Along with the sham device, the same generally accepted standard wound care procedures will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: On a weekly basis until the end of the 16 week treatment period
assessing device related and general adverse events
On a weekly basis until the end of the 16 week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing
Time Frame: On a weekly basis until the end of the 16 week treatment period or until complete wound closure
Percent of wounds achieving complete wound closure, wound granulation and percent change in ulcer size/area
On a weekly basis until the end of the 16 week treatment period or until complete wound closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

June 14, 2018

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 5, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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